Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study (CASA)

Implementing Collaborative Care to Alleviate Symptoms and Adjust to Heart Failure: A Pilot Study

The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure (CHF)
• Intervention / Treatment: Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness; Behavioral: Psychospiritual

Detailed Description

The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are:

1. A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes

   1. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
   2. a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and
   3. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
2. A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.

The specific aims of the study are to:

1. Examine intervention feasibility and determine preliminary estimates of intervention effect

   1. Determine patient participation rates and cohort retention
   2. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
2. Obtain qualitative feedback from study participants, the persons providing the intervention, and providers/leaders in primary care, mental health, palliative care, chaplaincy, and hospital operations.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • VA Eastern Colorado Health Care System, Denver, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
• be at least 18 years of age, able to read and understand English,
• have consistent access to a telephone

• at least one of the following:

  1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
  2. a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
  3. taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
  4. BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
  5. estimated creatinine clearance 30-80 mL/min.

Exclusion Criteria:

• previous diagnosis of dementia;
• active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
• comorbid metastatic cancer, given the focus on heart failure palliative care;
• nursing home resident; and
• diagnosis of bipolar disorder or schizophrenia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collaborative Care to Alleviate Symptoms and Adjust to Illness; A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.	Other: Collaborative Care to Alleviate Symptoms and Adjust to Illness; A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.; Other Names: Palliative symptom management and psychosocial care
Active Comparator: Psychospiritual; A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.	Behavioral: Psychospiritual; A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort Retention	Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Was Depression Addressed?	The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is "thoughts that you would be better off dead, or of hurting yourself in some way?"	3 months
Participation Rates	The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.	7 months
Adherence to the Study Protocol (CASA Arm Only)	The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as: how often is depression addressed with a treatment plan?; how often are care team recommendations placed as orders in the medical record?; how often are orders completed?	3 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Iowa
• Investigators: Principal Investigator: David Bekelman, MD MPH, VA Eastern Colorado Health Care System, Denver, CO

Publications and helpful links

General Publications

• Bekelman DB, Hooker S, Nowels CT, Main DS, Meek P, McBryde C, Hattler B, Lorenz KA, Heidenreich PA. Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial. J Palliat Med. 2014 Feb;17(2):145-51. doi: 10.1089/jpm.2013.0143. Epub 2013 Dec 11.
• Hooker SA, Ross K, Masters KS, Park CL, Hale AE, Allen LA, Bekelman DB. Denver Spirited Heart: Mixed-Methods Pilot Study of a Psychospiritual Intervention for Heart Failure Patients. J Cardiovasc Nurs. 2017 May/Jun;32(3):226-235. doi: 10.1097/JCN.0000000000000337.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: palliative care; heart failure; delivery of health care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RRP 11-239; CRICC Pilot (Other Grant/Funding Number: Denver REAP (CRICC) Pilot Grant)